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Lifeline for hunter syndrome patients: continued access to Brain-Targeting therapy

NCT ID NCT05795361

AVAILABLE Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program offers continued treatment with idursulfase-IT (TAK-609), given directly into the spinal fluid, plus standard intravenous Elaprase, for children and adults with Hunter syndrome who have cognitive impairment. It is only open to people who completed earlier studies of this combination. The goal is to maintain any benefits they experienced and keep the disease under control.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
idursulfase-IT (TAK-609) given into the spinal fluid, plus intravenous Elaprase
What this could lead to
If successful, this program could provide ongoing disease control and cognitive benefit for people with Hunter syndrome who have cognitive impairment.
What could go wrong
This is an open-access program, not a new trial, so it does not test whether the treatment works. Risks include side effects from the spinal injections or the implanted delivery device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

mucopolysaccharidosis type 2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HUNTER SYNDROME

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ann and Robert H Lurie Childrens Hospital of Chicago

    AVAILABLE

    Chicago, Illinois, 60611, United States

  • Board of Regents of the University of Nebraska

    AVAILABLE

    Omaha, Nebraska, 68198-5450, United States

  • Division of Medical Genetics, University of Utah

    AVAILABLE

    Salt Lake City, Utah, 84112, United States

  • H.C.U. de Valladolid

    AVAILABLE

    Valladolid, 47003, Mexico

  • Hospital Universitario Reina Sofia

    AVAILABLE

    Córdoba, 14004, Spain

  • Instituto Nacional de Pediatria

    AVAILABLE

    Coyoacán, Mexico City, 4530, Mexico

  • Jackson Memorial Hospital University of Miami

    AVAILABLE

    Miami, Florida, 33101, United States

  • Joseph M. Sanzari Children's Hospital

    AVAILABLE

    Hackensack, New Jersey, 07601, United States

  • NYU Langone Medical Center

    AVAILABLE

    New York, New York, 10017, United States

  • Phoenix Childrens Hospital

    AVAILABLE

    Phoenix, Arizona, 85015, United States

  • Queensland Childrens Hospital

    AVAILABLE

    South Brisbane, Queensland, QLD 4101, Australia

  • Randall Children's Hospital at Legacy Emanuel

    AVAILABLE

    Portland, Oregon, 97227, United States

  • Royal Manchester Children's Hospital - PPDS

    AVAILABLE

    Manchester, M13 9WL, United Kingdom

  • Seattle Children's Hospital - PIN

    AVAILABLE

    Seattle, Washington, 98105, United States

  • The Children's Hospital of Philadelphia

    AVAILABLE

    Philadelphia, Pennsylvania, 19104, United States

  • The Cleveland Clinic Foundation

    AVAILABLE

    Cleveland, Ohio, 44195, United States

  • The Nemours Foundation

    AVAILABLE

    Wilmington, Delaware, 19803, United States

  • The Regents of the University of California

    AVAILABLE

    Oakland, California, 94609, United States

  • The University of North Carolina

    AVAILABLE

    Chapel Hill, North Carolina, 27514, United States

  • UPMC Childrens Hospital of Pittsburgh

    AVAILABLE

    Pittsburgh, Pennsylvania, 15224, United States

  • Vanderbilt Children's Hospital

    AVAILABLE

    Nashville, Tennessee, 37232-7610, United States

  • Washington University

    AVAILABLE

    Washington, Missouri, 63130, United States

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